Drug recall
Cetirizine Hydrochloride Tablets, 10mg, 100 count bottles, Manufactured for PACK Pharmaceuticals, LLC, Buffalo…
FDA recall event 60187 · Class II · Unique Pharmaceutical Labs (Div. of J.B. Chemicals & Pharm.)
Key facts
| Event ID | 60187 |
|---|---|
| Recall numbers | D-852-2012 |
| Recalling firm | Unique Pharmaceutical Labs (Div. of J.B. Chemicals & Pharm.) |
| Product type | Drugs |
| Products | Cetirizine Hydrochloride Tablets, 10mg, 100 count bottles, Manufactured for PACK Pharmaceuticals, LLC, Buffalo Grove, IL, Manufactured by Unique Pharmaceutical Laboratories, Mumbai, India |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling; Label Error on Declared Strength; outer label indicates strength as 10mg however inner label indicates strength as 5mg |
| Initiation date | Oct 19, 2011 |
| Termination date | Aug 7, 2012 |
| City | Panoli, |
| Country | India |
| FEI number | 3003053502 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports